A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder

Last updated: July 18, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Depression

Treatment

Placebo

JNJ-89495120

Clinical Study ID

NCT06785012
89495120MDD2001
89495120MDD2001
  • Ages 18-64
  • All Genders

Study Summary

The purpose of this study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary psychiatric diagnosis of recurrent major depressive disorder, withoutpsychotic features, based on clinical assessment using diagnostic and statisticalmanual of mental disorders (DSM)-5 criteria and confirmed with the miniinternational neuropsychiatric interview (MINI)

  • Participant had to have at least one previous major depressive disorder (MDD)episode prior to their current episode

  • Were first diagnosed with depression before the age of 55

  • Are in a current episode of depression: Episode length must be at least 2 months butnot longer than 24 months

  • Have taken 0, 1, or 2 treatments for depression in your current episode

  • Body mass index (BMI) within the range 18 to 35 kilograms per square meter (kg/m^2)at screening

Exclusion

Exclusion Criteria:

  • Treatment with vagus nerve stimulation (VNS), electroconvulsive therapy (ECT),transcranial magnetic stimulation (TMS), deep brain stimulation (DBS), orketamine/esketamine within the current or past major depressive episodes

  • Current or past DSM-5 diagnosis of bipolar disorder, psychotic disorders, borderlinepersonality disorder, antisocial personality disorder, or currentobsessive-compulsive disorder

  • Post-traumatic stress disorder within the past three years of screening

  • Dementia, any dementing disease, intellectual disability, or neurocognitive disorder

  • History of Alcohol and Substance use disorders within 6 months of screening, withthe exclusion of nicotine, caffeine, and mild cannabis use disorder, according tothe MINI and Clinical Assessment

  • Known allergies, hypersensitivity, or intolerance to JNJ-89495120 or its excipients

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 26, 2024
Estimated Completion Date:
June 26, 2026

Connect with a study center

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